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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Loose or Intermittent Connection (1371); Failure to Advance (2524); Material Deformation (2976)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/05/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of recx2943 showed no other similar product complaint(s) from this lot number.
 
Event Description
Nurse on cardiology dep placed a powerglide pro under supervision of a clinical specialist from bd. Get access on first attempted and have blood return. Advance the guidewire into the vein, it is a resistant, so she pull the wire back and lower the angel of the needle. The needle tip seems to be in the middle of the vein. Advance the guidewire, no resistant. Advance the catheter about 5 cm, then it not able to advance it more. They decided to end the insertion and pull out the needle. At this point they see that the wire is loosened from the device, and a part of it is visible in the insertion place. The nurse pull it out. The wire is damaged, the part that has been in the patient has spun up, is long and crooked. The device will be sent in. After inspection it seems it is complete and nothing is left in the patient's vein.
 
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Brand Name20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key8462066
MDR Text Key140452982
Report Number3006260740-2019-00717
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number6F120100
Device Lot NumberRECX2943
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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